Is TUDCA legal?
Written by Aaron CuhaReviewed Sep 2026
- US: Sold as a supplement
- UK: Sold as a supplement
- AU: Available as a supplement / complementary medicine
- CA: Sold as a supplement
The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.
All four countries, side by side
| What we list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Not approved | Not approved | Not approved | Not approved |
| Legal category | Sold as a supplement | Sold as a supplement | Available as a supplement / complementary medicine | Sold as a supplement |
| Note | Sold as a dietary supplement. The combination product containing it was approved for ALS. Its maker then pulled it from sale after a failed final-stage study. Its parent compound, ursodeoxycholic acid, is a prescription medicine with its own page on this site. | None recorded | None recorded | Sold as a natural health product. The maker of the ALS combination product chose to give up its Health Canada approval. |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: Not approved on its own. A fixed mix of sodium phenylbutyrate and taurursodiol was FDA-approved for ALS. Its maker then chose to pull it from sale, after the final-stage PHOENIX study found no change in its main measure of how well patients could function. TUDCA on its own is sold as a dietary supplement.. Reviewed Sep 2026.
Country by country
Is TUDCA legal in the United States?
TUDCA can be sold in the United States as a supplement or cosmetic ingredient. Its legal category is "Sold as a supplement". That is not approval as a drug. FDA has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full United States answerIs TUDCA legal in the United Kingdom?
TUDCA can be sold in the United Kingdom as a supplement or cosmetic ingredient. Its legal category is "Sold as a supplement". That is not approval as a drug. MHRA has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full United Kingdom answerIs TUDCA legal in Australia?
TUDCA can be sold in Australia as a supplement or cosmetic ingredient. Its legal category is "Available as a supplement / complementary medicine". That is not approval as a drug. TGA has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full Australia answerIs TUDCA legal in Canada?
TUDCA can be sold in Canada as a supplement or cosmetic ingredient. Its legal category is "Sold as a supplement". That is not approval as a drug. Health Canada has not checked any health claim made for it. Versions you inject, and "research use only" versions, fall outside supplement rules, so that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full Canada answerTUDCA in sport and the military
Whether TUDCA is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. Before you compete or get tested, look up TUDCA by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
Related compounds
General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.